FDA

The Feds 'Modernize' Food Safety Without Making Food Safer

Proposed FDA food-safety rules under the FSMA show the expensive campaign to modernize food safety shouldn't be confused with one that improves food safety.

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FDA
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Can the federal government spend hundreds of millions of dollars on food-safety regulations without making Americans or our food much safer? Sadly, the answer appears to be yes.

In late September, the Food and Drug Administration (FDA) released two key sets of revised rules intended to implement the Food Safety Modernization Act (FSMA), the federal food-safety law passed in 2011.

The FSMA, widely billed as the most important update of the nation's food-safety regulations in 75 years, is intended, as the FDA puts it, "to ensure the U.S. food supply is safe by shifting the focus from responding to contamination to preventing it."

Last year, though, two sets of rules the FDA proposed to adopt under the law created a firestorm. As I wrote (see here and here, for example), the proposed rules would have forced many small farmers and local food entrepreneurs to adopt onerous, expensive, and unnecessary farming practices and procedures. Among the barriers proposed under the rules were tough new regulations for using organic fertilizer, a ban on using spent grains to feed livestock, and a host of costly new regulations for growing tree fruits.

Many small farmers and their supporters argued in comments to the agency that the rules would erect costly new hurdles for them without ensuring a safer food supply for consumers.

"The FSMA has the real potential to make it impossible for small produce growers to make a living by requiring costly and we feel unnecessary alterations to the way produce is handled," wrote Pennsylvania small farmers Donald and Rebecca Kretschmann, who grow fruits and vegetables, in comments they submitted to the FDA.

Thousands of comments echoing those submitted by the Kretschmanns forced the FDA to pull back the proposed FSMA rules, effectively sending the agency back to the drawing board.

The result is, in part, what the FDA issued in late September—updated versions of two proposed rules that center on produce and good manufacturing practices. (The agency also issued two other revised rules I don't focus on here.)

Small farmers and other growing food entrepreneurs were right to criticize the agency's proposed rules for jeopardizing their livelihoods. But another little-noticed element of the proposed rules was that despite their intended effect, they wouldn't have made Americans or the food we eat much safer.

According to CDC data, there are 48 million cases of food-borne illness each year.

The earlier versions of the two proposed FSMA rules, as I wrote last year, would reduce that figure by, at best, only between 3.7 percent and 5.7 percent.

Now, according to FDA estimates released in September, the expected benefits of the proposed rules are even less apparent.

For example, the FDA says the newly revised produce rule will reduce up to 1.57 million cases of food-borne illness.

The revised proposed rules pertaining to manufacturing are even less promising.

"As in our original proposal," the agency writes, "we lack sufficient information to fully estimate the proposed rule's likely benefits…. We do not expect that all of these illnesses will be prevented; rather, we expect that the rule would prevent some portion from occurring. We estimate that there are close to 1,000,000 illnesses each year that are attributable to FDA-regulated food products that would fall under the scope of this proposed rule."

Taken together, the results are underwhelming. Even giving the FDA the maximum possible benefit of the doubt—even if I assume that the FDA will prevent every single one of the illnesses the agency itself doesn't expect to prevent—the maximum benefit of these FSMA rules would be a reduction of 5.4 percent of food-borne illnesses. Meanwhile, the agency also floats a break-even figure of reducing 228,000 cases of food-borne illness under the manufacturing rules. This would mean the two rules, taken together, would reduce cases of food-borne illness by up to 3.7 percent.

So the new range for FSMA "success" is a paltry reduction in cases of food-borne illness of between 3.7 percent and 5.4 percent.

And that's an optimistic view. I suspect even the lower figure isn't likely to be attained (at least not due to anything contained in the FSMA rules), given that the agency offers no floor on its estimate that the revised produce rule will reduce up to 1.57 million cases of food-borne illness. If the revised produce rule prevents 1 million cases instead of 1.57 million, for example, then we're looking at a lower end of a 2.6 percent overall reduction.

These revised proposed FSMA rules should make clear that the campaign to modernize food safety shouldn't be confused with one that improves food safety.

It's easy to see the disconnect between what Congress promised with the Food Safety Modernization Act and what the FDA is capable of delivering.

The American food supply is among the safest in the world. The FDA can take some credit for that. Effective regulations pertaining to fraud (particularly food mis-branding and adulteration) are already on the books.

But that's a small piece of the puzzle. The FDA can't wash the hands of every eater and cook in the country. What's more, the self-interest of people and of companies large and small means they provide us with food that's safe. When they don't, food-safety lawyers rightly sue them and we stop buying their products.

All this is not to say that the FSMA is entirely without merit. A few facets of the law actually make sense. Giving the FDA mandatory recall authority, as the law did, is an important tool for forcing foods that have been found to be a definitive hazard off the market. But these revised FSMA regulations will not make our food—or us—demonstrably safer. Instead, they'll most benefit the FDA, in the form of adding hundreds of millions of dollars to the agency's budget.

In hyping the FSMA, the FDA referred to food-borne illness as "a significant public health burden that is largely preventable." The former is true. The latter may be true. But it's also true that the proposed revised FSMA regulations have little to do with preventing food-borne illness.

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  1. …the proposed rules would have forced many small farmers and local food entrepreneurs to adopt onerous, expensive, and unnecessary farming practices and procedures.

    The reason for most regulation is to price smaller or less well-connected competition out of the market.

    1. That’s attributing to conspiracy whatnis adequately explained by idiocy. Sure, big farming concerns probably had some input, and that WAS their goal. But the bean counters were just trying to jutify their jobs and their raises and promotions. That’s hard to do if you’re simply doing your frickin’ job, at least in Wonderland on the Potomac.

      The core probllem with the feds is that the Federal Government tries to do too gaoddamned much, and in consequence doesn’t do very much of it well and is always scrambling for money.

      1. The bean counters didn’t pass the legislation. Duplicitous politicians did. And you can be damned certain that they did so because large contributors wanted them to.

  2. OT:
    That didn’t take long
    ‘Cause, you know, it was Richard Branson himself who designed the spacecraft. That, and it was totally related to the rocket explosion in VA a few days earlier.
    This was a gift to the NASA fan-boys

    1. yeah,the space shuttle had such a good safety record.What ,2 explosions in 187 trips? NASA is a money hungry government pig

    2. Amazon.com zillionaire Jeff Bezos has his own spacecraft company?because what can better qualify a man to build machines able to travel to space than selling books, TVs and lawn furniture online?

      I wonder if this fuckwit realizes that the people who head private space companies are not the same people who are DESIGNING THE FUCKING SPACE-CRAFT.

      1. He must think that someone who owns a portfolio is really biting off more than he can chew.

  3. Well, I’m impressed, but I suspect you’ll be sharpening the knives.

    http://www.shalomlife.com/cult…..fter-fury/

    1. I became a Christian man, and not in a f*cking b*llshit way ? in a very real way.

      Practitioners of zen require thousands of hours of meditation and, on average, about a decade before they achieve satori. Most Christians seem to believe they get their salvation by accepting an invitation in the matter of a few seconds, though some do insist on weekly or annual upkeep.

      Economically speaking, that’s a pretty good deal for someone who’s in the market for spiritual insurance. Little wonder there are so many more Good Christian Men like Shia bumping around than there are Thomas Keatings or DT Suzukis.

      1. Becoming Christian is the end of one journey and the beginning of another. As you get deeper into the faith, then what you said in the first flush of convert enthusiasm can seem cringeworthy.

        If LeBouef stays in the same spiritual condition as in his early conversion years, that would be a problem, but if he shows an amendment of life and progress in his Christian walk – and it’s early days to say he won’t – then that would be great.

        1. And I bet you can find Zen afficionados who are shallow enough to make LeBouef look like Thomas Aquinas.

          1. I don’t disagree, especially among American practitioners of zen (not to pick on zen, it’s just been fashionable for the last couple of generations as opposed to the relatively less glamorous spiritual life of a Trappist). People get excited about it until they start hearing about roshis drinking themselves to death or sexually abusing their students or supporting/being Nazis or doing all the other terrible things that people by dint of being people, regardless of whether they’ve had peak experiences or not.

            But Shia has been a known asshat for a long time now, and dropping the f-bomb while testifying to God’s ineffable grace tickles me in a way that SoCal zen masters with wandering hands can’t quite manage.

            1. I depends on whether he’s just doing something fashionable or sincerely “asking, seeking, knocking.”

              When I think “fashionable,” I don’t automatically think “Jewish guy converts to Christianity.” So whatever’s going on, he at least thinks he’s had some key spiritual experience.

  4. Democratic gaffes ignored by media –

    http://ht.ly/DvZq9

  5. a significant public health burden that is largely preventable

    I actually would dispute the first part AND the second part, relative to the number of discrete events.

    Everyone eats multiple times a day. Multiple ingredients go into each thing people eat.

    That’s tens of billions of risk events a day.

    How many of those risk events result in anything adverse? Hundreds a day, maybe?

    Regardless of the absolute public health impact of food contamination overall, the public health risk profile of any individual sale of food is incredibly low.

  6. Anyone else hungover?

    1. WHY MUST YOU SHOUT?

  7. Looking back before modern canning and freezing,when thousands of people died of food poisoning due to home canning,and most people had few good vegetables to eat during most of the year I see no problem.Modern farming and transportation made it possible to eat a varied diet any where in the U.S.A. Proper diet and cooking is up to you.

  8. my best friend’s sister-in-law makes $81 /hr on the internet . She has been out of a job for ten months but last month her check was $12399 just working on the internet for a few hours. try this web-site…

    ???? http://www.cashbuzz40.com

  9. this is basically just politicians doing SOMETHING because they have a job so they have to look like they’re doing SOMETHING prompted by irrational, fear-mongering media.
    Our food was extremely safe before and will remain so with or without new regulation

    When I overthrow Castro in Cuba (using drones 🙂 ) and re-start the country, I’ll make sure to add in the constitution that it’s probably a good thing if politicians and/or regulators are doing nothing most of the time.

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